Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction

Deutsches Herzzentrum Muenchen548 enrolled

Overview

Randomized comparison of two different anticoagulation strategies: prasugrel plus bivalirudin versus clopidogrel plus heparin in patients with acute myocardial infarction undergoing emergency catheterization and coronary intervention.

Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for patients with acute ST-segment elevation myocardial infarction (STEMI). Additional anticoagulation therapy prior or during intervention plays an important role in the short- and long-term outcomes after PPCI. Two separate studies have shown significant benefit against conventional therapy based on clopidogrel and heparin for two recently approved drugs: the direct thrombin inhibitor bivalirudin and the thienopyridine prasugrel. In the HORIZONS-AMI trial, bivalirudin after pretreatment with clopidogrel resulted in improved net clinical outcomes. However, during the first 24 hours after PPCI an increase in the stent thrombosis rate was observed with bivalirudin therapy. Prasugrel has been shown to be superior to clopidogrel in patients with acute coronary syndromes undergoing PCI. The benefit in reduction of ischemic complication was even greater in the subset of patients with STEMI without any increase in the bleeding risk and with a significant reduction in the stent thrombosis rate. Expectedly, the synergic actions of prasugrel and bivalirudin may maximize the benefit of antithrombotic therapy for STEMI patients undergoing PPCI.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

548

Conditions

Myocardial Infarction

Interventions

PrasugrelDRUG

60 mg prasugrel as loading dose prior to PPCI

BivalirudinDRUG

IV bolus 0.75 mg/kg of body weight followed by an infusion of 1.75 mg/kg/hour during the PPCI

ClopidogrelDRUG

600 mg clopidogrel as loading dose before PPCI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients presenting within 24 hours from the onset of symptoms with STEMI 2. Informed, written consent 3. In women with childbearing potential a pregnancy test is obligatory. Exclusion Criteria: 1. Age \< 18 years 2. Cardiogenic shock 3. Active bleeding; bleeding diathesis; coagulopathy 4. History of gastrointestinal or genitourinary bleeding \<2 months 5. Refusal to receive blood transfusion 6. Major surgery in the last 6 weeks 7. History of intracranial bleeding or structural abnormalities 8. Suspected aortic dissection 9. Heparin-induced thrombocytopenia 10. Any previous stroke 11. Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI 12. Known relevant hematological deviations: Hb \<100g/l, Thromb. \<100x10\^9/l 13. Use of coumadin derivatives within the last 7 days 14. Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), COX-2 inhibitors, prasugrel 15. Known malignancies or other comorbid conditions with life expectancy \<1 year 16. Known severe liver disease, severe renal failure 17. Known allergy to the study medications 18. Previous enrollment in this trial 19. Pregnancy

Locations (3)

Deutsches Herzzentrum Muenchen

Munich, Bavaria, Germany

Klinikum rechts der Isar, Technische Universitaet Muenchen

Munich, Bavaria, Germany

Herzzentrum der Segeberger Kliniken

Bad Segeberg, Germany

Outcomes

Primary Outcomes

composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding

Time frame: 30 days

Secondary Outcomes

all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosis

Time frame: 30 days

major bleeding complications

Time frame: 30 days

cardiac death

Time frame: 30 days

Data from ClinicalTrials.gov

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